Clinical Study Report (CSR)
The content of CSR is detailed in the ICH guideline E3. A CSR provides an explanation of the critical design features, methodology, statistical and clinical description, individual patient data, and analysis of the completed study. ADI Intellect follows the guidelines including synoptic, abbreviated and full submission reports, and we make sure that each aspect is covered to the detail.
Case Report Form (CRF) Design Solution
Standard Operating Procedure Development (SOP)
Patient Safety Narratives (PSN)
We firmly believe in the value of excellent bibliographic searches as one of the foundations of good regulatory submissions and clear argumentation to support filings. Our dedicated teams of bibliographical investigators gather relevant information and place each individual search through an intensive data-filtration process. Good pursuits are indeed demanding and time-consuming for all, except for the experts!